Recall of Guidant Pacemakers, ICDs

Thousands of Patients Implanted With Possibly Faulty Heart Devices

Medically Reviewed by Louise Chang, MD on June 27, 2006

June 27, 2006 -- Boston Scientific says 27,200 patients -- 13,800 in the U.S. -- have been implanted with possibly faulty heart devices made by its recently acquired subsidiary, Guidant.

The devices contain a faulty capacitor that may cause them to fail. Five failures have been reported -- four in patients already implanted, and one during the implant operation. None of these patients died, although two pacemaker patients fainted when their devices lost power.

Boston Scientific is recalling:

  • Some Insignia and Nexus pacemakers
  • Contak Renewal TR and TR 2 cardiac resynchronization pacemakers
  • Ventak Prizm 2, Vitality, and Vitality 2 ICDs (implantable cardioverter defibrillators)

Warning Letters

Last Friday, the company sent warning letters to doctors and patients. The letters advise patients implanted with these devices to see their doctor as soon as possible. It's not yet clear how many of the devices are faulty.

Company policy, subject to some restrictions, offers a replacement device at no cost and up to $2,500 in unreimbursed medical expenses.

Boston Scientific says it is still investigating the failures, and will promptly provide patients and doctors with any new information.

In a Monday news conference, Boston Scientific said it expects additional recalls of Guidant heart devices. The current recall is the second. Last month, the company announced that nearly 1,000 Guidant heart devices had a defect that could cause their batteries to fail.

Boston Scientific recently acquired Guidant after a bidding war with Johnson & Johnson.

"Boston Scientific believes in notifying physicians in a timely, transparent, and responsible manner," Boston Scientific CEO Jim Tobin said, in a news release.

Show Sources

SOURCES: FDA news release. Boston Scientific news release. Boston Scientific webcast. Boston Scientific letters to doctors and patients.

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